BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX16MM NO TIP

    MDR report key: 14721886 · Received June 16, 2022

    Report

    Report Number
    3008114965-2022-00396
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 27, 2022
    Report Date
    August 18, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. (B)(6) PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6920524. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(6) AND WAS DETERMINED TO BE ACCEPTABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATION FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE HOSPITAL ENCOUNTERED A DEFECT WITH THE 4.0MM X 16MM NO DISTAL TIP ENTERPRISE® 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC401600 / 6920524). IT WAS REPORTED THAT THE DEVICE DID NOT DEPLOY NORMALLY. THE STENT DID NOT SLIDE INTO THE MICROCATHETER; IT DEPLOYED IN THE MICROCATHETER AND AS A RESULT, THE PHYSICIAN USED A SECOND DEVICE TO TREAT THE PATIENT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 07-JUNE-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING A STENOTIC VESSEL DURING PROCEDURE FOR STROKE TREATMENT. THE PHENOM¿ 21 MICROCATHETER (MEDTRONIC) WAS USED. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO VISIBLE KINKS OR OTHER DAMAGES NOTED ON THE MICROCATHETER; NO OTHER SIMILAR DEVICE WENT THROUGH THE MICROCATHETER. THERE WAS NOTHING UNUSUAL NOTED ON THE COMPLAINT DEVICE PRIOR TO USE. THE REPORTED ISSUE DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO THE REPORTED PRODUCT ISSUE. THE SAME MICROCATHETER WAS USED WITH THE REPLACEMENT DEVICE, ANOTHER 4.0MM X 16MM NO DISTAL TIP ENTERPRISE® 2 VRD AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 4.0MM X 16MM NO DISTAL TIP ENTERPRISE® 2 VRD AND THE CONCOMITANT PHENOM¿ 21 MICROCATHETER WERE RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. THE STENT COMPONENT WAS OBSERVED ALREADY DETACHED FROM THE REST OF THE UNIT / COMPLAINT DEVICE. THE STENT COMPONENT WAS INSPECTED; THERE WERE NO ABNORMALITIES (I.E., NO BROKEN STRUTS, NO KINKS) WERE OBSERVED. THE INTRODUCER AND THE DELIVERY WIRE WERE NOT RETURNED FOR EVALUATION. DUE TO THE INCOMPLETE DEVICE RETURN, FUNCTIONAL EVALUATION AND ANALYSIS COULD NOT BE PERFORMED TO INVESTIGATE THE ISSUE REPORTED THAT THE STENT WAS IMPEDED IN THE MICROCATHETER, OR ¿THE STENT DID NOT SLIDE INTO THE MICROCATHETER.¿ THE STENT COMPONENT MUST STILL BE INSIDE THE INTRODUCER IN ORDER FOR THE DEVICE TO UNDERGO FUNCTIONAL ANALYSIS TO DETERMINE THE CAUSE OF WHY THE DEVICE ENCOUNTERED THE REPORTED ISSUE THAT RESULTED IN IT NOT TO BE ABLE TO SLIDE INTO THE MICROCATHETER. THE COMPLAINT DEVICE WAS RETURNED WITHOUT THE INTRODUCER AND THE DELIVERY WIRE; THE STENT COMPONENT WAS ALREADY IN A DETACHED STATE WHEN IT WAS RECEIVED. THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT THAT THE 4.0MM X 16MM NO DISTAL TIP ENTERPRISE® 2 VRD DID NOT DEPLOY NORMALLY, THE STENT DID NOT SLIDE IN THE MICROCATHETER AND PREMATURELY DEPLOYED IN THE MICROCATHETER AS A RESULT WAS CONFIRMED BASED ON THE RETURNED DEVICE WITH THE STENT COMPONENT ALREADY DETACHED. HOWEVER, THERE WERE NO OBSERVABLE ABNORMALITIES ON THE STENT COMPONENT THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. IT IS POSSIBLE THAT CLINICAL AND/OR PROCEDURE FACTORS INCLUDING DEVICE MANIPULATION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6920524. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT DETACH THE STENT IF IT IS NOT PROPERLY POSITIONED IN THE VESSEL. DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. H.6: THE CODE ¿NO FINDINGS AVAILABLE (C20)¿ WAS USED IN THE INVESTIGATION FINDINGS BECAUSE THE REPORTED ISSUE RELATED TO THE STENT BEING IMPEDED IN THE MICROCATHETER COULD NOT BE TESTED DUE TO THE STENT RETURNED ALREADY IN A DETACHED CONDITION, WITHOUT THE INTRODUCER AND THE DELIVERY WIRE. THIS CODE CORRESPONDS WITH THE ¿CAUSE NOT ESTABLISHED (D15)¿ IN THE INVESTIGATION CONCLUSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB 27-JUL-2022. THE RETURN PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE HOSPITAL ENCOUNTERED A DEFECT WITH THE 4.0MM X 16MM NO DISTAL TIP ENTERPRISE® 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC401600 / 6920524). IT WAS REPORTED THAT THE DEVICE DID NOT DEPLOY NORMALLY. THE STENT DID NOT SLIDE INTO THE MICROCATHETER; IT DEPLOYED IN THE MICROCATHETER AND AS A RESULT, THE PHYSICIAN USED A SECOND DEVICE TO TREAT THE PATIENT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 07-JUNE-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING A STENOTIC VESSEL DURING PROCEDURE FOR STROKE TREATMENT. THE PHENOM¿ 21 MICROCATHETER (MEDTRONIC) WAS USED. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO VISIBLE KINKS OR OTHER DAMAGES NOTED ON THE MICROCATHETER; NO OTHER SIMILAR DEVICE WENT THROUGH THE MICROCATHETER. THERE WAS NOTHING UNUSUAL NOTED ON THE COMPLAINT DEVICE PRIOR TO USE. THE REPORTED ISSUE DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO THE REPORTED PRODUCT ISSUE. THE SAME MICROCATHETER WAS USED WITH THE REPLACEMENT DEVICE, ANOTHER 4.0MM X 16MM NO DISTAL TIP ENTERPRISE® 2 VRD AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2473861 ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 6920524

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male PHENOM¿ 21 MICROCATHETER (MEDTRONIC).